Expanded Access trials sponsored by us, in partnership with manufacturers
A source of real world treatment outcomes data in your targeted population(s)
Experts in site feasibility and full cost recovery
A complete solution to the increasing expectations of wider engagement and access
Expanded Access programs are “Treatment-Use” clinical trials for patients who cannot take part in research trials for the particular therapeutic or diagnostic in serious unsolved disease areas. We take over the burden of sponsoring and managing these programs, because (a) we have specialist knowledge and experience, and (b) manufacturers must spend their resources on the controlled studies required for marketing approval.
Group-level Expanded Access clinical trials (not to be confused with single-patient “compassionate use”) allow meaningful numbers of patients and their physicians to explore a new investigational treatment with a well designed protocol and supply-chain to work in harmony with the continued clinical development of the particular treatment.
When integrated into the drug development cycle, Expanded Access trials bring many benefits to the drug company, including wider patient engagement, increased chances of discovering response-predictive biomarkers, and information that leads to more-highly targeted pivotal trials in historically difficult diseases.
WideTrial sponsors both large group and small to medium sized group EAPs. The allowable size and timing of the program depends on many factors, including the degree of medical need, the safety profile of the product, and the quality of existing clinical data. We have seen every kind of case in the 30 year history of U.S. Expanded Access. We’ll devise the right access strategy for your product.
Jon Katz, MD
Alison Bateman-House, PhD
WideTrial is a third-party sponsor of group-level Expanded Access programs (EAPs). The primary objective of any EAP is to provide pre-approval treatment options in situations of unmet medical need. For us, the secondary objective is to generate clinical data from a larger and more representative set of patients within the target indication. Many patients do not meet the enrollment criteria of traditional research trials, and bringing them into the drug development process can be a win for all parties.
Jess Rabourn is the founder and CEO of WideTrial, the culmination of several projects aimed at improving the treatment landscape for unsolved serious diseases. Since 2010 he has been a nationally recognized speaker on pre-approval access and the economics of breakthrough clinical development. He is executive producer of the Expanded Access Summit., the annual forum on integrating well-designed Expanded Access trials into the modern drug development process. Through his consulting firm, Jess has guided several pharmaceutical companies and disease organizations on regulation and strategy in this area. He is a member of the American Academy of Neurology and was lead author of the Expanded Access section of the submitted draft for FDA's Guidance on ALS Drug Development. Prior to his life sciences career, Jess spent 15 years in the investment management industry at firms in San Francisco and New York. He earned the Chartered Financial Analyst designation in 2004.
Ian Manger has 25 years of technology and business leadership in clinical drug development. He served as Director of Science and Technology at Stanford Research Institute (SRI) and was Director of Applications Development at Fluidigm. His work in assay development and biomarker discovery led to advances in preclinical and clinical product development practices. Ian’s non-profit work includes advisory board service for Global Oncology, which brings advanced cancer treatment to underserved populations. Ian earned his PhD in Biochemistry at Oxford and continued postdoctoral research in Immunology at Stanford School of Medicine
Peggy Schrammel is a recognized leader in late-phase clinical development has run the operations and business development of global CROs over the past 20+ years. Peggy served as the VP, Scientific Affairs for PAREXEL ACCESS, where she had oversight of several areas of the business unit, including 1) Epidemiology, in which she ensured scientific support for both new opportunities and ongoing projects; 2) Managed Access Programs, in which she steadily increased the yearly new business and turned the group into a substantial service line within PAREXEL ACCESS; and 3) PAREXEL ACCESS Project Management Office (PMO) in which ensured compliance with corporate delivery metrics, meeting variable revenue targets, developing ACCESS wide core training and establishing consistent approaches to delivery of service-line projects.Peggy was VP, Portfolio Management and Project Leadership within the former PACE group and had operational oversight for a global team of over 12 Portfolio Directors and nearly 100 Project Leaders.
Sridhar Byrappa has 10+ years experience working on large global clinical trials at Merck, Schering Plough, and Accenture. He is the co-founder and CEO of iClinical Inc, which provides a mobile cloud data platform for managing and monitoring the clinical experiences of study participants. Sridhar is a recognized leader in clinical trial innovation and has pioneered advanced machine learning and artificial intelligence solutions to strengthen design and operation. He has a PhD in Microbiology/Immunology and an MBA in strategic management.